Venous Thrombosis
Conditions
Brief summary
This is an observational trial to estimate the incidence of deep vein thrombosis (DVT) in total knee replacement patients who received an intraoperative dose of tranexamic acid.
Detailed description
This study is anticipated to consist of 30 participants over 18 years of age scheduled for total knee arthroplasty at Sandoval Regional Medical Center with administered intraoperative tranexamic acid, who do not meet the exclusion criteria. The patients will be examined on postoperative day 1. Lower-extremity ultrasound will be used to screen for deep vein thrombosis (DVT). Incidence data for DVT will then be compared with the historical incidence rate at our institution for total knee arthroplasty without the use of tranexamic acid, which is approximately 12%. Patients found on screening to have deep vein thrombosis will be referred for appropriate care.
Interventions
DRUGTranexamic Acid
Intravenous or local administration of TXA, in any dosage
Sponsors
University of New Mexico
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients scheduled for total knee arthroplasty at Sandoval Regional Medical Center with an intraoperative dose of tranexamic acid
Exclusion criteria
* Previous deep vein thrombosis or pulmonary embolism episode * Known coronary artery disease or peripheral vascular disease * Previously diagnosed hypercoagulable states (e.g. Leiden factor V, antiphospholipid antibody, protein C or S deficiency) * Pregnancy * Creatinine clearance less than 30 ml/min * Non-fluency in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Deep Vein Thrombosis | One day | Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Knee Replacement Patients Receiving TXA Patients who receive tranexamic acid during total knee replacement surgery
Tranexamic Acid: Intravenous or local administration of TXA, in any dosage | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Knee Replacement Patients Receiving TXA | — |
|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 25 participants | — |
| Sex: Female, Male Female | 17 Participants | — |
| Sex: Female, Male Male | 8 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Deep Vein Thrombosis
Incidence of deep vein thrombosis diagnosed by ultrasound scan on postoperative day 1
Time frame: One day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Knee Replacement Patients Receiving TXA | Deep Vein Thrombosis | 2 Participants |